An interventional study of tDCS active and tDCS sham in Dysarthria and Stroke, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
The proposed study aims to determine if transcranial direct current stimulation can enhance the effect of speech therapy in post-stroke patients with dysarthria.
A total of 60 Cantonese-speaking post-stroke patients who are suffering from dysarthria will be recruited and randomly divided into real tDCS and sham groups. All the participants will receive individualized speech therapy based on the results of their speech assessment.
For the real tDCS group, an anodal high-definition tDCS of 2 milliamperes (mA) lasting for 20 minutes will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy. For the sham tDCS group, stimulation given during speech therapy will only last for 30 seconds in order to cause a similar sensation on the scalp as the real stimulation group. There will be a total of 10 daily sessions during a 2-week period.
60 studies on the registry are indexed under Dysarthria; 19 are open to participants now.
This study's enrollment of 3 is below the median of 39 across 44 interventional studies indexed under Dysarthria.
Browse Dysarthria studies →The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
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Exclusion Criteria:
A total of 60 Cantonese-speaking post-stroke patients who are suffering from dysarthria will be recruited and randomly divided into real tDCS and sham groups.
Device: tDCS active
A total of 60 Cantonese-speaking post-stroke patients who are suffering from dysarthria will be recruited and randomly divided into real tDCS and sham groups.
Device: tDCS sham
An anodal high-definition tDCS of 2 mA lasting for 20 minutes will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy.
An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy.
Perceptual speech assessments
All participants will be required to produce a sustained vowel /a/, repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/), read a standard Chinese paragraph and have a 1-2 mins conversation with the researcher.
Time frame: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Communication effectiveness measures
The Modified Communication Effectiveness Index (CETI-M) is a 10-item patient-reported measure of change in functional communication ability.
Time frame: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Kinematic Measurements
The lip and tongue function during speech production will be traced real time and objectively using the 3D-Electromagnetic Articulography (EMA, AG501-system).
Time frame: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Acoustic measurements
Acoustic measurements will be obtained from both sustained vowel phonation and connected speech.
Time frame: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Quality of Life measurement
The Chinese version of The Quality of Life of the Dysarthric Speaker (QOL-DyS) questionnaire will be used to assess participants' subjective speech related quality of life.
Time frame: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2020 to primary completion in Nov 2023, 35 months.
Of 34 interventional studies with no phase under Dysarthria, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's 35 months is close to that.
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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